Gait Analysis of Anterior Versus Posterior Approach in Performance of Total Hip Arthroplasty

May 18, 2022 updated by: Medacta USA

Gait Analysis of Anterior vs. Posterior Approach in Performance of Total Hip Arthroplasty: A Multi-Centre, Prospective Trial

The primary objectives of the study is to compare gait kinematics and the return to normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the direct anterior approach versus the posterior approach. Gait kinematics will be measured using the IDEEA LifeGait device from Minisun (Fresno, CA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study of two different surgical approaches to THA, direct anterior vs posterior approach in approximately 64 patients that meet the standard criteria for the implantation of primary total hip replacement utilizing the Medacta implants and have elected to undergo THA.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Surprise, Arizona, United States, 85374
        • Sun Valley Orthopedic Surgeons
    • California
      • Fresno, California, United States, 93710
        • D. Kevin Lester, MD
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Peak Orthopedics
    • Utah
      • Saint George, Utah, United States, 84790
        • Intermountain Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients fulfilling the standard criteria for the implantation of primary total hip arthroplasty
  • Those presenting with primary or secondary osteoarthritis
  • Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use)

Exclusion Criteria:

  • Pregnant women or women who plan to conceive within the year following surgery
  • Inflammatory arthritic condition
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
  • Those already treated with a failed Total Hip Arthroplasty (THA)
  • Muscle contracture around the hip joint
  • Individuals who have undergone organ transplant
  • Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
  • Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
  • Individuals who have had a THA on the contra-lateral side within the 6 months.
  • Individuals who have undergone a THR on the contra-lateral side and whose outcome is considered unsatisfactory or not good
  • Individuals requiring bilateral hip replacement
  • Individuals whose body mass index (BMI; kg/m2) >40
  • Individuals with active or suspected infection or sepsis
  • Individuals with chronic renal failure as defined by the need for dialysis
  • Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV
  • History of drug and/or substance abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Anterior Surgical Approach
(AMIS)
Procedure: Anterior Approach
Anterior Minimal Invasive Surgery (AMIS)
ACTIVE_COMPARATOR: Posterior Approach Group
Posterior surgical approach for total hip replacement.
Procedure: Posterior Approach
Other Names:
  • Posterior Surgical Approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach.
Time Frame: Pre-Op, (2 weeks if fully ambulatory), 6 weeks, 3 months, 1 year
Pre-Op, (2 weeks if fully ambulatory), 6 weeks, 3 months, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate/compare two surgical approaches (direct anterior vs. posterior): Patient improvement (subjective and objective) following THA using the HHS. Patient overall function and pain following THA using the WOMAC. Post operative radiological findings
Time Frame: Pre-Op, 6 weeks, 3 months, 1 year
Pre-Op, 6 weeks, 3 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta USA

Collaborators

Medacta International SA

Investigators

  • Study Director: Tyler Goldberg, MD, Medacta USA Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (ESTIMATE)

August 4, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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